Remote Ischemic Preconditioning Combined to Local Ischemic Postconditioning in Acute Myocardial Infarction (RIRE-1)

This study is currently recruiting participants.
Verified July 2011 by University Hospital, Angers
Sponsor:
Collaborators:
Fédération Française de Cardiologie
Société Française de Cardiologie
Information provided by:
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT01390142
First received: July 6, 2011
Last updated: July 8, 2011
Last verified: July 2011

July 6, 2011
July 8, 2011
July 2011
December 2012   (final data collection date for primary outcome measure)
Infarct size [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Infarct size as assessed by 72 hours area under curve serum CK-MB and cardiac magnetic resonance imaging at 3-month follow-up
Infarct size [ Time Frame: 3 months ]
Infarct size as assessed by 72 hours area under curve serum CK-MB and cardiac magnetic resonance imaging at 3-month follow-up
Complete list of historical versions of study NCT01390142 on ClinicalTrials.gov Archive Site
  • Microvascular obstruction [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    Microvascular obstruction as assessed by cardiac magnetic resonance imaging at 5-day follow-up
  • Left ventricular remodeling [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Left ventricular remodeling as assessed by cardiac magnetic resonance imaging at 5-day and 3-month follow-up
  • Microvascular obstruction [ Time Frame: 5 days ]
    Microvascular obstruction as assessed by cardiac magnetic resonance imaging at 5-day follow-up
  • Left ventricular remodeling [ Time Frame: 3 months ]
    Left ventricular remodeling as assessed by cardiac magnetic resonance imaging at 5-day and 3-month follow-up
Not Provided
Not Provided
 
Remote Ischemic Preconditioning Combined to Local Ischemic Postconditioning in Acute Myocardial Infarction
Remote Ischemic Preconditioning Combined to Local Ischemic Postconditioning in Acute Myocardial Infarction (RIRE-1)

RIRE-1 is a randomized, open-label with blinded end-point study that will test the hypothesis that remote ischemic preconditioning initiated at the time of the admission in the cathlab reduces infarct size in ST-segment elevation myocardial infarction (STEMI) patients treated with percutaneous coronary intervention (PCI). Furthermore, it will determine whether a combined approach remote ischemic preconditioning and local ischemic postconditioning can further reduce infarct size. Infarct size will be determined by cardiac magnetic resonance imaging at 3-month follow-up and with 72 hours area under curve of CK-MB.

In the management of STEMI, prompt reperfusion of the jeopardized myocardium is the most effective way to limit infarct size, which is a major determinant of morbidity and mortality. However, restoration of blood flow may paradoxically have deleterious consequences and lead to lethal myocardial ischemia-reperfusion injury. Local ischemic postconditioning (IPost) and remote ischemic preconditioning (RIPer) are promising methods to decrease ischemia-reperfusion injury.

The hypothesis tested in this research proposal is that RIPer initiated at the time of the admission in the cathlab reduces infarct size in STEMI patients treated with PCI. Furthermore, the investigators will determine whether a combined approach RIPer + IPost can further reduce infarct size.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Myocardial Infarction
  • Procedure: Control
    Deflated blood pressure cuff placed on upper arm for 30min
  • Procedure: RIPer
    Blood pressure cuff placed on upper arm and inflated to 200 mmHg for 5 min and then deflated for 5 min. This cycle is initiated as soon as possible after patient admission in the cathlab and repeated 3 times in total.
  • Procedure: RIPer + IPost
    Blood pressure cuff placed on upper arm and inflated to 200 mmHg for 5 min and then deflated for 5 min. This cycle is initiated as soon as possible after patient admission in the cathlab and repeated 3 times in total. Within the first minute of re-established coronary flow by primo-stenting, the same balloon is re-inflated for 1 min and then deflated for 1min. This procedure of balloon inflation/deflation is repeated 4 times in total.
  • Experimental: Control
    Intervention: Procedure: Control
  • Active Comparator: RIPer
    Remote ischemic preconditioning
    Intervention: Procedure: RIPer
  • Active Comparator: RIPer + IPost
    Remote ischemic preconditioning and Local ischemic postconditioning
    Intervention: Procedure: RIPer + IPost
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
December 2012
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age > 18
  • ST-Segment elevation myocardial infarction <6h
  • Written informed consent

Exclusion Criteria:

  • Previous Q-wave myocardial infarction or previous coronary artery bypass graft
  • Cardiogenic shock
  • Cardiac arrest resuscitated before angioplasty
  • Infarct related artery : circumflex coronary artery, right coronary artery after segment 3, left main, diagonal and marginal branches, and all coronary artery with jeopardized myocardium estimated too small.
  • TIMI 2 or 3 before angioplasty
  • Collateral branches Rentrop >1
  • TIMI 0 or 1 flow grade after PCI
  • Any contraindications to magnetic resonance imaging
  • Allergy to gadolinium
  • Patient refusal / patient not having provided written informed consent
Both
18 Years and older
No
Contact: Fabrice Prunier, MD, PhD +33 (0)2 41 35 51 47 FaPrunier@chu-angers.fr
France
 
NCT01390142
PHRC 2011-06
Not Provided
University Hospital, Angers, Direction des Affaires Médicales et de la Recherche
University Hospital, Angers
  • Fédération Française de Cardiologie
  • Société Française de Cardiologie
Principal Investigator: Fabrice Prunier, MD, PhD University Hospital, Angers
University Hospital, Angers
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP